title: Australasian Resuscitation In Sepsis Evaluation trial statistical analysis plan.
abstract: BACKGROUND
  The Australasian Resuscitation In Sepsis Evaluation (ARISE) study is an international, multicentre, randomised, controlled trial designed to evaluate the effectiveness of early goal-directed therapy compared with standard care for patients presenting to the ED with severe sepsis.
  
  
  OBJECTIVE
  In keeping with current practice, and taking into considerations aspects of trial design and reporting specific to non-pharmacologic interventions, this document outlines the principles and methods for analysing and reporting the trial results. The document is prepared prior to completion of recruitment into the ARISE study, without knowledge of the results of the interim analysis conducted by the data safety and monitoring committee and prior to completion of the two related international studies.
  
  
  METHODS
  The statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. The data collected by the research team as specified in the study protocol, and detailed in the study case report form were reviewed. Information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation and other related therapies, and other relevant data are described with appropriate comparisons between groups. The primary, secondary and tertiary outcomes for the study are defined, with description of the planned statistical analyses.
  
  
  RESULTS
  A statistical analysis plan was developed, along with a trial profile, mock-up tables and figures. A plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies, along with adverse events are described. The primary, secondary and tertiary outcomes are described along with identification of subgroups to be analysed.
  
  
  CONCLUSIONS
  A statistical analysis plan for the ARISE study has been developed, and is available in the public domain, prior to the completion of recruitment into the study. This will minimise analytic bias and conforms to current best practice in conducting clinical trials.
authors.affiliation: Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St Leonards, New South Wales, Australia; Northern Clinical School, Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Anthony
authors.initials: A
authors.lastname: Delaney
authors.forename: Sandra L
authors.initials: SL
authors.lastname: Peake
authors.forename: Rinaldo
authors.initials: R
authors.lastname: Bellomo
authors.forename: Peter
authors.initials: P
authors.lastname: Cameron
authors.forename: Anna
authors.initials: A
authors.lastname: Holdgate
authors.forename: Belinda
authors.initials: B
authors.lastname: Howe
authors.forename: Alisa
authors.initials: A
authors.lastname: Higgins
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Presneill
authors.forename: Steve
authors.initials: S
authors.lastname: Webb
mesh_terms: D044362:Australasia; D003627:Data Interpretation, Statistical; D006801:Humans; D012151:Resuscitation / Q000706:statistics & numerical data*; D018805:Sepsis / Q000628:therapy*
keywords: randomised controlled trial; sepsis; statistical analysis plan